Untitled Letters 2021
These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information.
Office of Prescription Drug Promotion
| Company / Individual | Product / Issue | Issued Date |
|---|---|---|
|
Emgality
|
BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use |
12/13/2021 |
|
Alkindi Sprinkle
|
NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules |
8/9/2021 |
|
Amgen
|
BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use |
7/72021 |
|
Biohaven Pharmaceuticals
|
NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use |
3/8/2021 |